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Tuesday, September 07, 2010

Ghostwritten articles overstate benefits of HRT and downplay harms

Ghostwritten articles overstate benefits of hormone replacement therapy and downplay harms: "The first academic analysis of the 1500 documents unsealed in recent litigation against the pharmaceutical giant Wyeth (now part of Pfizer) reveals unprecedented insights into how pharmaceutical companies use ghostwriters to insert marketing messages into articles published in medical journals. Dr. Adriane Fugh-Berman, associate professor in the Department of Physiology at Georgetown University Medical Center in Washington DC, analyzed dozens of ghostwritten reviews and commentaries published in medical journals and journal supplements that were used to promote unproven benefits and downplay harms of Prempro—a brand of menopausal hormone therapy (HT)—and to cast competing therapies in a negative light. These articles were widely circulated to drug reps and doctors to disseminate the company's marketing messages. The analysis appears in this week's PLoS Medicine.

Wyeth used a medical education & communication company, DesignWrite, to produce ghostwritten articles in order to mitigate the perceived risks of breast cancer associated with HT, to defend the unsupported cardiovascular ''benefits'' of HT, and to promote off-label, unproven uses of HT such as the prevention of dementia, Parkinson's disease, vision problems, and wrinkles, writes Fugh-Berman.

The analysis revealed that DesignWrite was paid US$25,000 to ghostwrite articles reporting clinical trials, including four manuscripts on the HOPE trials of low-dose Prempro. DesignWrite was also assigned to write 20 review articles about the drug, for which they were paid US$20,000 each.

The analysis concludes that 'Given the growing evidence that ghostwriting has been used to promote HT and other highly promoted drugs, the medical profession must take steps to ensure that prescribers renounce participation in ghostwriting, and to ensure that unscrupulous relationships between industry and academia are avoided rather than courted.'

In July 2009, PLoS Medicine, represented by the public interest law firm Public Justice, and The New York Times acted as intervenors in litigation against menopausal hormone manufacturers by 14,000 plaintiffs whose claims related to the development of breast cancer while taking the hormone therapy Prempro (conjugated equine estrogens). This resulted in a US federal court decision to release approximately 1500 documents to the public. The Wyeth Ghostwriting Archive is available at http://www.plosmedicine.org/static/ghostwriting.action or through the UCSF Drug Information Document Archive at http://dida.library.ucsf.edu/documents.jsp

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Funding: The author received no specific funding for this article.

Competing Interests: Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper. She was not paid for any part of researching or writing this paper. Dr. Fugh-Berman directs PharmedOut, a Georgetown University-based project founded with public money from the Attorney General Consumer and Prescriber Grant program and currently supported by individual donations.

Competing Interests: Dr. Fugh-Berman was a paid expert witness on behalf of plaintiffs in the litigation referred to in this paper. She was not paid for any part of researching or writing this paper. Dr. Fugh-Berman directs PharmedOut, a Georgetown University-based project founded with public money from the Attorney General Consumer and Prescriber Grant program and currently supported by individual donations.

Other information about PLoS Medicine relevant to journalists, bloggers and press officers, including an outline of our approach to the media, our embargo policy, and how you can re-use of PLoS Medicine material, see the Speaking of Medicine blog: http://speakingofmedicine.plos.org/media/

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The term "PR" means something completely different to a medical doctor!
"We are all born ignorant, but one must work hard to remain stupid." -Benjamin Franklin.
"It takes a wise doctor to know when not to prescribe."
- Gracian.